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    Summary
    EudraCT Number:2006-003395-35
    Sponsor's Protocol Code Number:ASAC-CUPS/1-06
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2006-003395-35
    A.3Full title of the trial
    Clinical trial pilot noncontrolled of effectiveness of 600 mg/day of extract of curcuma standardized to 12% in curcumina in the treatment of patients with moderate-serious chronic psoriasis in plates.
    Ensayo clínico piloto no controlado de eficacia de 600 mg/día de extracto de cúrcuma estandarizado al 12% en curcumina en el tratamiento de pacientes con psoriasis crónica en placas moderada-grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of effectiveness of 600 mg/day of extract of curcuma in the treatment of patients with moderate-serious chronic psoriasis in plates.
    Ensayo clínico de eficacia de 600 mg/día de extracto de cúrcuma en el tratamiento de pacientes con psoriasis moderada-grave en placas
    A.4.1Sponsor's protocol code numberASAC-CUPS/1-06
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASAC PHARMACEUTICAL INTERNATIONAL A.I.E.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportASAC PHARMACEUTICAL INTERNATIONAL A.I.E
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASAC PHARMACEUTICAL INTERNATIONAL A.I.E
    B.5.2Functional name of contact pointASAC PHARMA
    B.5.3 Address:
    B.5.3.1Street AddressC/SAGITARIO 14
    B.5.3.2Town/ cityALICANTE
    B.5.3.3Post code03006
    B.5.3.4CountrySpain
    B.5.4Telephone number0034965286700
    B.5.5Fax number0034965286434
    B.5.6E-mailjoaquin_diaz@asac.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name EXTRACTO DE CURCUMA CENTRUM
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS CENTRUM S.A
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameExtracto de Curcuma Centrum
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCURCUMIN
    D.3.9.1CAS number 458-37-7
    D.3.9.2Current sponsor code610079
    D.3.9.3Other descriptive nameDRY EXTRACT OF CURCUMA LONGA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-serious chronic Psoriasis in plates.
    Psoriasis crónica en placas moderada-grave
    E.1.1.1Medical condition in easily understood language
    Moderate-serious chronic Psoriasis in plates.
    Psoriasis crónica en placas moderada-grave
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objetivo principal: Los objetivos principales serán tres, dos de eficacia y uno de seguridad:
    a) Establecer el porcentaje de respondedores
    b) Establecer el curso temporal de la respuesta
    c) Seguridad: Nº de sesiones y cantidad total de radiación recibida hasta alcanzar la respuesta terapéutica
    E.2.2Secondary objectives of the trial
    Objetivos secundarios:
    a) Registro de acontecimientos adversos
    b) Cambios en lesiones índice representativas (> 2)
    c) Cambios en el área de superficie corporal afectada
    d) Cambios en la escala total de signos de severidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Individuos de ambos sexos que tras haber recibido información sobre el diseño, los fines del proyecto, los posibles riesgos que de él pueden derivarse y de que en cualquier momento pueden denegar su colaboración y abandonar el estudio, otorguen por escrito su consentimiento para participar en el ensayo.
    2. Edad entre 18 y 65 años de edad.
    3. Los sujetos deben presentar un diagnóstico clínico de psoriasis en placas definida como moderada-grave, desde al menos 6 meses antes de la selección para el estudio. Para esta clasificación no se tendrán en cuenta las localizaciones no evaluables mediante el Índice de Superficie y Gravedad de la Psoriasis (PASI): palmo-plantar, pliegues, cuero cabelludo o uñas.
    4. Candidatos a fototerapia o tratamiento sistémico de la psoriasis.
    5. No presentar anormalidades clínicamente relevantes en los análisis de hematología.
    6. Niveles de aspartato aminotransferasa, alanina aminotransferasa, fosfatasa alcalina y gamma glutamiltransferasa < 1.5 veces el límite superior de la normalidad para los valores estándar del laboratorio.
    7. Bilirrubina total dentro de la normalidad para el laboratorio. Creatinina sérica < 1.5 mg/dl.
    8. Test de embarazo negativo (para las mujeres).
    E.4Principal exclusion criteria
    1. Sujetos afectos de otras enfermedades clínicamente relevantes en grado moderado-severo.
    2. Sujetos que presenten otras formas de psoriasis que no sea en placas.
    3. Sujetos con psoriasis activa inducida por fármacos.
    4. Mujeres embarazadas.
    5. Sujetos que hayan recibido tratamiento farmacológico tópico o sistémico de la psoriasis en las 4 semanas anteriores.
    6. Sujetos que hayan recibido tratamiento fototerápico de la psoriasis en las 4 semanas anteriores.
    7. Mujeres en edad fértil en tratamiento con contraceptivos hormonales.
    8. Antecedentes de hipersensibilidad a la cúrcuma o derivados.
    9. Contraindicación para fototerapia UV-A.
    10. Sujetos diagnosticados de trastornos del conducto biliar con bloqueo del mismo.
    11. Antecedentes de cólico biliar en el año previo.
    12. Sujetos que estén en una situación tal que, en opinión del investigador, pueda interferir en su participación óptima en el estudio.
    13. Sujetos que estén participando en otro estudio con fármacos en investigación en los 3 meses previos.
    14. Incapacidad para seguir las instrucciones o colaborar durante el desarrollo del estudio
    E.5 End points
    E.5.1Primary end point(s)
    a) two for the percentage of responders, as recommended by the European Medicines Agency:
    1. Overall clinical assessment by the investigator (PGA), qualifying as responders patients with the degree of "almost clean" or "clean" at each visit
    2. No. of patients whose Area and Severity Index of Psoriasis (PASI) improved by more than 75% over baseline (PASI> 75%) at each visit
















    a) use two for the percentage of responders, as recommended by the European Medicines Agency:
    1. Overall clinical assessment by the investigator (PGA), qualifying as responders patients with the degree of "almost clean" or "clean" at each visit
    2. No. of patients whose Area and Severity Index of Psoriasis (PASI) improved by more than 75% over baseline (PASI> 75%) at each visit
    b) Time course of the response:
    1. Time to achieve PASI> 75%
    2. No. of sessions of phototherapy to reach PASI> 75%
    c) Safety:
    1. Total number of sessions and total amount of radiation received
    2. - Adverse Events
    Other secondary endpoints of efficacy evaluation:
    a) No. of patients PASI> 50% at each visit
    b) No. of patients PASI> 90% (remissions) at each visit
    a) Se utilizarán dos para establecer el porcentaje de respondedores, siguiendo las recomendaciones de la Agencia Europea del Medicamento:
    1. Valoración clínica global por el investigador (PGA), calificando como respondedores a los pacientes con el grado de ?prácticamente limpio?, o ?limpio? en cada visita
    2. Nº pacientes cuyo Índice de Superficie y Gravedad de la Psoriasis (PASI) mejore en más de un 75% sobre la basal (PASI > 75%) en cada visita
    E.5.1.1Timepoint(s) of evaluation of this end point
    b) Time course of the response:
    1. Time to achieve PASI> 75%
    2. No. of sessions of phototherapy to reach PASI> 75%
    c) Safety:
    1. Total number of sessions and total amount of radiation received
    2. - Adverse Events
    b) Curso temporal de la respuesta:
    1. Tiempo hasta alcanzar PASI > 75%
    2. Nº de sesiones de fototerapia hasta alcanzar PASI > 75%
    c) Seguridad:
    1. Nº total de sesiones y cantidad total de radiación recibida
    2.- Acontecimientos adversos
    E.5.2Secondary end point(s)
    Other secondary endpoints of efficacy evaluation:
    Otras variables secundarias de evaluación de eficacia serán:
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) No. of patients PASI> 50% at each visit
    b) No. of patients PASI> 90% (remissions) at each visit
    a) Nº pacientes PASI > 50% en cada visita
    b) Nº pacientes PASI > 90% (remisiones) en cada visita
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    PILOT NON CONTROLLED CLINICAL TRIAL
    ENSAYO CLINICO PILOTO NO CONTROLADO
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Not available

    A patient was considered assessable in full if the study ends. A patient will complete the study or because they have attended all study visits during the 8 weeks of it, meeting the established treatment protocol, or because it reaches a PASI >90%
    No disponible

    Un paciente se considera evaluable en su totalidad si finaliza el estudio. Un paciente habrá finalizado el estudio o bien porque haya acudido a todas las visitas del estudio durante la 8 semanas del mismo, cumpliendo el protocolo terapéutico establecido, o bien porque alcance un valor PASI < 90%
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No hay previsto.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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